Atlas FDA

FLOSEAL HEMOSTATIC MATRIX

FDA premarket approval P990009/S013 · decided 2005-03-10

Approval details

PMA number
P990009
Supplement
S013
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
FLOSEAL HEMOSTATIC MATRIX
Generic name
Agent, absorbable hemostatic, collagen based
Applicant
Baxter Healthcare Corp
Date received
2002-11-18
Decision date
2005-03-10
Days to decision
843 days
Decision code
APPR
Product code
LMF
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Round Lake, IL
Statement
APPROVAL FOR AN ALTERNATE KIT CONFIGURATION THAT CONTAINS A HUMAN THROMBIN COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

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510(k) clearances by this applicant

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INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874)Baxter Healthcare Corp2013-01-10
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868)Baxter Healthcare Corp2013-01-08
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